BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFI-10, TREK MEDICAL LIGHT SOURCE

    MDR report key: 58333 · Received December 18, 1996

    Report

    Report Number
    2183477-1996-00001
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Date of Event
    November 1, 1996
    Report Date
    December 16, 1996
    Manufacturer
    ESCALON MEDICAL CORP.
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, A LIGHT BULB RUPTURED CAUSING A LOUD NOISE WHICH FRIGHTENED THE SURGEON AND PT. NO RESULTING INJURY OCCURRED. CONTACT WAS MADE WITH THE MEDICAL FACILITIES IN WHICH THE FAILURE OCCURRED. THEY REPORTED LITTLE USE WITH THE LIGHT SOURCE BEFORE THE FAILURE. THEY DEMONSTRATED KNOWLEDGE WITH RESPECT TO BULB REPLACEMENT. WHICH IS, PREVENTING THE LAMP TO COME INTO CONTACT WITH EXPOSED FINGERS AS THIS WILL CAUSE THE LAMP TO BURST AS DESCRIBED. THEY ALSO INDICATED THAT THE DEVICE WAS PLACED IN SUCH A MANNER TO ALLOW AMPLE AIR FLOW THROUGH THE BOTTOM OF THE UNIT FOR LAMP COOLING AND WAS PLUGGED INTO THE PROPER OUTLET FOR 110VAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SFI-10, TREK MEDICAL LIGHT SOURCE LIGHT SOURCE FQP ESCALON MEDICAL CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO